US2025082806A1PendingUtilityA1

Sterility testing drain actuator base

Assignee: RAPID MICRO BIOSYSTEMS INCPriority: Sep 8, 2023Filed: Sep 8, 2023Published: Mar 13, 2025
Est. expirySep 8, 2043(~17.1 yrs left)· nominal 20-yr term from priority
A61L 2/28C12Q 1/22C12M 37/06
66
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Claims

Abstract

Exemplary embodiments relate to drain actuators for cassettes used in sterility testing. A sterility cassette may have a spring-loaded drain to allow fluid flow through a porous membrane. To activate the drain, upwards pressure is applied to the spring during kit preparation through an actuator base. The actuator base may automatically actuate the drain when the cassette is inserted into the actuator base, and may be separate from or integral with a thermoformed drain tray. When the sterility cassette is removed from the tray, the base automatically shuts the drain. The actuator base has features that: maintain the rotational alignment between the tray and cassette; actuate the drain port on the bottom of the cassette; minimally inhibit flow out of the drain; minimize the collection of drain fluid; provide a rigid support across the drain tray surface; and stay locked into the drain tray when the cassette is removed.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A drain actuator for a sterility cassette comprising:
 a drain actuator base having a drain outlet defined therein; and   a drain actuator provided in the drain outlet and configured to interface with a drain plunger base of a drain plunger provided in the sterility cassette, the drain actuator sized and shaped to provide an opening pressure on the drain plunger when the drain plunger base interfaces with the drain actuator.   
     
     
         2 . The drain actuator of  claim 1 , wherein the drain actuator is substantially triangular in shape. 
     
     
         3 . The drain actuator of  claim 1 , wherein the drain actuator has a flat surface for interfacing with the drain plunger base, the flat surface provided between rounded sides. 
     
     
         4 . The drain actuator of  claim 1 , further comprising one or more alignment features sized and shaped to mate with corresponding features of a drain tray to maintain a rotational alignment between the drain tray and the sterility cassette. 
     
     
         5 . The drain actuator of  claim 1 , wherein the drain actuator base comprises one or more ridges that extend in a radial direction across a surface of the drain actuator base. 
     
     
         6 . The drain actuator of  claim 1 , further comprising an inner circumferential ridge around the drain outlet. 
     
     
         7 . The drain actuator of  claim 1 , further comprising an outer circumferential ridge provided at an outer circumference of the drain actuator base. 
     
     
         8 . The drain actuator of  claim 1 , further comprising one or more fasteners configured to fix the drain actuator to a drain tray. 
     
     
         9 . The drain actuator of  claim 1 , wherein the drain actuator is formed from a thermoplastic. 
     
     
         10 . A sterility testing kit comprising:
 a sterility cassette comprising a drain assembly; and   the drain actuator of  claim 1 .   
     
     
         11 . The kit of  claim 10 , wherein the drain assembly comprises a spring. 
     
     
         12 . The kit of  claim 10 , wherein the drain assembly comprises the drain plunger. 
     
     
         13 . The kit of  claim 10 , wherein the drain assembly further comprises a sealing element. 
     
     
         14 . The kit of  claim 10 , further comprising a drain tray. 
     
     
         15 . A method of assembling a sterility kit comprising:
 inserting a sterility cassette onto an actuator base, the inserting causing a drain in the sterility cassette to automatically open;   injecting a sample into the sterility cassette, the sample being filtered through a membrane; and   removing the sterility cassette from the actuator base, the removing causing the drain in the sterility cassette to automatically close.   
     
     
         16 . The method of  claim 15 , further comprising subjecting the drain actuator to sterilization. 
     
     
         17 . The method of  claim 15 , further comprising assembling the drain on a base assembly of the sterility cassette. 
     
     
         18 . The method of  claim 15 , wherein the actuator base is integral with a drain tray. 
     
     
         19 . The method of  claim 15 , further comprising attaching the actuator base to a drain tray. 
     
     
         20 . The method of  claim 19 , wherein removing the sterility cassette from the actuator base causes the actuator base to remain attached to the drain tray.

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